Table 9.
Study | Disease severity | Treatment and dose | Treatment group for analysis | Number of patients randomized | Mean age, years | Mean disease duration, years | Withdrawals, % |
---|---|---|---|---|---|---|---|
Johnsen et al73 | Active RA despite DMARD DAS28 CRP 6.0–6.2 | ETN 25 mg twice weekly | ETN 2 × 25 mg/week | 26 | 50.5 (median) | 12.5 (median) | 12 |
ETN 50 mg twice weekly | ETN 2 × 50 mg/week | 51 | 55.0 (median) | 15.0 (median) | 16 | ||
Miyasaka74 | Active disease despite prior treatment with ≥1 DMARD | Placebo every other week | PLA | 87 | 53.4 | 8.4 | 59 |
ADA 20 mg every other week | ADA 20 mg/2 weeks | 87 | 54.8 | 10.0 | 38 | ||
ADA 40 mg every other week | ADA 40 mg/2 weeks | 91 | 56.9 | 9.9 | 35 | ||
ADA 80 mg every other week | ADA 80 mg/2 weeks | 87 | 54.3 | 9.5 | 25 | ||
Moreland et al80 | Active disease despite 1–4 conventional DMARDs | Placebo | PLA | 44 | 55 | 77% had duration >5 years | 48 |
ETN 0.25 mg/m2 | ETN 0.25 mg/m2 | 46 | 54 | 39 | |||
ETN 2 mg/m2 | ETN 2 mg/m2 | 46 | 52 | 22 | |||
ETN 16 mg/m2 | ETN 16 mg/m2 | 44 | 52 | 7 | |||
Moreland et al75 | Active RA (advanced) despite DMARD (>90% MTX exposed) | Placebo | PLA | 80 | 51 | 12 | 33 |
ETN 10 mg sc twice weekly | ETN 2 × 10 mg/week | 76 | 53 | 13 | 32 | ||
ETN 25 mg sc twice weekly | ETN 2 × 25 mg/week | 78 | 53 | 11 | 24 | ||
Nishimoto et al77 | Active, relatively severe disease despite ≥ 1 DMARD | Placebo | PLA | 53 | Median 53.0 | Median 8.4 | 47 |
TOC 4 mg/kg every 4 weeks | TOC 4 mg/kg/4 weeks | 54 | Median 53.5 | Median 7.3 | 4 | ||
TOC 8 mg/kg every 4 weeks | TOC 8 mg/kg/4 weeks | 55 | Median 56.0 | Median 8.3 | 7 | ||
Nishimoto et al76 | Active disease despite prior MTX for ≥8 weeks DAS28 6.1 | MTX 8 mg/week | MTX | 66 | 50.8 | 8.7 | 48 |
TOC 8 mg/kg iv every 4 weeks | TOC 8 mg/kg/4 weeks | 61 | 52.6 | 8.5 | 11 | ||
van de Putte et al79 | Active RA despite ≥ 1 DMARD DAS28 7.0–7.1 | Placebo | PLA | 70 | 50.2 | 9.4 | 33 |
ADA 20 mg weekly | ADA 20 mg/week | 72 | 53.7 | 10.4 | 14 | ||
ADA 40 mg weekly | ADA 40 mg/week | 70 | 52.6 | 10.0 | 17 | ||
ADA 80 mg weekly | ADA 80 mg/week | 72 | 53.2 | 10.1 | 8 | ||
van de Putte et al78 | Active long-standing severe RA despite ≥ 1 DMARD DAS 7.07 | Placebo | PLA | 110 | 53.5 | 11.6 | 56.4 |
ADA 20 mg every other week | ADA 20 mg/2 weeks | 106 | 53.1 | 9.3 | 35.8 | ||
ADA 20 mg weekly | ADA 20 mg/week | 112 | 54.4 | 11.3 | 29.5 | ||
ADA 40 mg every other week | ADA 40 mg/2 weeks | 113 | 52.7 | 10.6 | 28.3 | ||
ADA 40 mg weekly | ADA 40 mg/week | 103 | 51.8 | 11.9 | 14.6 |
Notes: Combe et al,42 Edwards et al,81 Kameda et al,46 Keystone et al,82 Maini et al,51 and van Riel et al47 – characteristics as per Table 3; treatments in bold are treatments of interest (licensed doses); PLA is the reference treatment.
Abbreviations: ADA, Adalimumab; DAS, Disease Activity Score; DMARD, disease-modifying anti-rheumatic drugs; ETN, etanercept; MTX, methotrexate; PLA, placebo; RA, rheumatoid arthritis; TOC, Tocilizumab.